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eConsent in clinical trials: What’s new and what’s yet to come?

An expert panel at Medidata’s NEXT London conference discussed the latest on adoption of electronic consent.

By Urtė Fultinavičiūtė, Clinical Trials Arena

Electronic informed consent, also known as eConsent, aids the informed consent process by including multimedia components and digital signatures. Its time-saving and logistical advantages benefit patients, investigators, clinical trial sites, and sponsors. While this approach to clinical trial decentralisation has been a frequent topic of discussion, its widespread use is yet to flourish.

The slow uptake of eConsent can be linked to health and competent authorities not knowing how to regulate it, Michael Tucker, managing partner of patient cloud at Dassault Systèmes, the acquirer of Medidata, tells Clinical Trials Arena on the sidelines of the Medidata NEXT London conference (March 7).

Tucker says that there has been a greater adoption of eConsent in the US and Canada, as these two countries have fewer regulators compared to regions like the EU. However, the regulatory landscape in Europe is changing, explained Valeria Orlova, regulatory strategy analyst at Medidata, in a panel session called “Two truths and a lie: what do sites really think about eConsent?”.

Orlova noted that the EU landscape was very fragmented, but in the past few years, there has been a collaborative effort from various stakeholders in the industry. As a result, the EMA released a recommendations paper on decentralised clinical trials in late December 2022, which offers a list of requirements and acceptance of eConsent in each country.

This paper is a first step towards the unified implementation of eConsent in European trials, but Orlova noted that each country may still require a different configuration of this tool. However, sponsors should not turn their back on eConsent because of this, and should instead choose a vendor or a CRO that can take over the configuration tasks, Tucker says. Read more …